Sensory Integration Therapy in Children With Congenital Brachial Plexus Injury: Developmental Outcomes

NCT07134049 | Recruiting

• 2 other identifiers: E-68552689-000-00004173157Hacettepe University
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the effectiveness of sensory integration therapy in reducing sensory, motor, and cognitive developmental impairments following Congenital Brachial Plexus Injury (CBPI), and to support the overall developmental processes of affected children.

Conditions

Obstetric Brachial Plexus Injury

Keywords

sensory integration; Cognitive development; Motor development; obstetric brachial plexus palsy

Outcome Measures

Primary Outcomes (1)

• Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III)

  The Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III) is a standardized assessment tool designed to evaluate the developmental functioning of infants and toddlers aged 1 to 42 months. It measures five key domains: Cognitive, Language (Receptive and Expressive), Motor (Fine and Gross), Social-Emotional, and Adaptive Behavior. The Bayley-III is widely used in clinical and research settings to identify developmental delays and to monitor developmental progress over time

  The assessment will be conducted at the beginning of the treatment and repeated at the end of the 8-week treatment period.

Secondary Outcomes (3)

• Dunn Infant/Toddler Sensory Profile (7-35 months)

  The assessment will be conducted at the beginning of the treatment and repeated at the end of the 8-week treatment period.

• Active Movement Scale (AMS)

  The assessment will be conducted at the beginning of the treatment and repeated at the end of the 8-week treatment period

• Modified Mallet Grading System (MMGS)

  he assessment will be conducted at the beginning of the treatment and repeated at the end of the 8-week treatment period.

Study Arms (2)

intervention group

EXPERIMENTAL

Participants in this group receive individualized sensory integration therapy sessions once a week for 8 weeks, in addition to their routine physiotherapy program. Each session lasts approximately 45 minutes and is based on the core principles of sensory integration therapy. The intervention includes activities involving tactile, vestibular, proprioceptive, auditory, and visual stimuli, tailored to each child's sensory processing needs. Therapy is provided in a sensory-enriched and safe environment, and aims to promote adaptive responses, motor planning, self-regulation, and functional skills. Sessions are play-based and structured to support engagement and motivation.

Other: sensory integration therapy

control group

NO INTERVENTION

Participants in this group will not receive any sensory integration therapy during the 8-week study period. Instead, they will continue with their existing routine physiotherapy program, which may include general motor exercises, range of motion activities, and other standard therapeutic practices. No additional sensory-based interventions will be introduced. This group serves as a comparator to assess the effects of sensory integration therapy provided to the experimental group

Interventions

sensory integration therapy OTHER

Sensory Integration Therapy (SIT) is a client-centered rehabilitation approach aimed at improving adaptive and functional responses to sensory stimuli in changing environments. It is based on structured, individualized activities conducted in enriched sensory environments. These environments are designed to be engaging and motivating for children through the use of interactive and playful tasks that match their sensory processing profiles. Sensory integration plays a key role in motor planning, postural control, attention, and emotional regulation. Deficits in sensory integration-particularly in vestibular, tactile, and proprioceptive systems-may result in poor muscle tone, difficulty with balance and coordination, and impaired motor planning. These issues can negatively impact the development of gross motor, fine motor, language, and academic skills. For this reason, sensory-based interventions that support neural organization and promote adaptive responses are commonly recommended i

intervention group

Eligibility Criteria

• Age: 7 Months - 35 Months
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Confirmed diagnosis of obstetric brachial plexus injury (OBPI) Age between 7 and 35 months No additional diagnosed neurological, psychiatric, and/or muscular disorders No diagnosed mental retardation or cognitive disorder that would prevent participation in assessments Written informed consent from parents or legal guardians

You may not qualify if:

• Severe visual or hearing impairment preventing participation in assessments Participation in another experimental rehabilitation program within the last 3 months

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe Univeristy

Ankara, Turkey (Türkiye)

RECRUITING

Study Officials

• Çiğdem Öksüz, PhD, Professor,

  Hacettepe University Faculty of Health Sciences, Department of Occupational Therapy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

elif cimilli, MSc

CONTACT

+905469598168; e.ciminli19@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc, Principal Investigator, Occupational Therapist (MSc)

Study Record Dates

• First Submitted: August 8, 2025
• First Posted: August 21, 2025
• Study Start: June 23, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 21, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)